The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus (Kappa-III)

Technical University of Munich

Status: Completed

Conditions: Endoscopic Diagnosis in Esophagus

Treatments: Procedure: cap assisted upper endoscopy; Procedure: standard upper endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02883621

218/16 s

Details and patient eligibility

About

Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip of the colonoscope, was proven to increase the adenoma detection rate during screening colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is still under investigations. The aim of this study is to compare the diagnostic yield of the CAE to the standard endoscopy in esophagus.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• indication for upper endoscopy
• age over 18 years
• ability to provide informed consent

Exclusion criteria

• known or suspected upper gastrointestinal strictures
• upper gastrointestinal bleeding
• previous upper endoscopy during the last three months
• American Society of Anesthesiologists class III or higher

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Group A

Active Comparator group

Description:

subjects receive standard upper endoscopy

Treatment:

Procedure: standard upper endoscopy

Group B

Experimental group

Description:

subjects receive cap assisted upper endoscopy

Treatment:

Procedure: cap assisted upper endoscopy